Kazia Therapeutics

Kazia Therapeutics Ltd. is a clinical stage oncology company It engages in the pharmaceutical research and development business. The company was founded by Graham Edmund Kelly in March 1994 and is headquartered in Sydney, Australia.

Kazia Therapeutics Ltd. is a clinical stage oncology company, which engages in the pharmaceutical research and development business. The company was founded by Graham Edmund Kelly in March 1994 and is headquartered in Sydney, Australia.

Company and FDA to meet in December to discuss potential pathways to registration of paxalisib in glioblastoma multiforme (GBM) Company updates to corporate presentation and participation in upcoming medical meetings SYDNEY , Nov. 4, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, announced that the U.S. Food and Drug Administration (FDA) has granted a Type C meeting with the Company in December 2024 to discuss the potential pathways to registration of Kazia's blood brain barrier penetrant PI3K/mTOR inhibitor, paxalisib, for the treatment of patients with newly diagnosed GBM. In July 2024, the Company announced results from the Phase II/III clinical trial, GBM-AGILE, in which newly diagnosed unmethylated patients with glioblastoma treated with paxalisib showed clinically meaningful improvement in a prespecified secondary analysis for overall survival.

Kazia Therapeutics Announces Granting of Type C Meeting with FDA to Discuss Potential Next Steps for Paxalisib in the Treatment of Newly Diagnosed Glioblastoma Multiforme

Treatment with 45mg paxalisib and radiotherapy demonstrated 67% partial response (PR) Over two-thirds of the patients at maximum tolerated dose (MTD) achieved intracranial response which compares favorably to historical response rates for whole brain radiation therapy alone SYDNEY , Oct. 2, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, announced the presentation of data from a Phase I study (NCT04192981) evaluating concurrent paxalisib and radiation therapy (RT) in patients for the treatment of solid tumor brain metastases (BM) or leptomeningeal metastases (LM) harboring PI3K pathway mutations at the American Society for Radiation Oncology 66th Annual Meeting (ASTRO 2024), which is taking place from September 29 - October 2, 2024, in Washington, D.C. "The encouraging response rates observed from this Phase 1 study suggests that the concurrent administration of the investigational brain penetrant PI3K inhibitor, paxalisib, in combination radiation therapy appears to be a viable treatment approach for addressing the tumor radioresistance in patients harboring PI3K pathway mutations," said John Friend, M.D.

Kazia Therapeutics Announces Presentation of Promising Phase I Data Evaluating Concurrent Paxalisib and Radiation Therapy in Patients with Solid Tumor Brain Metastases or Leptomeningeal Metastases Harboring PI3K Pathway Mutations at the American Society for Radiation Oncology 66th Annual Meeting

SYDNEY , Sept. 23, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to announce the presentation of data highlighting promising clinical activity of EVT801 in high grade serous (HGS) Ovarian Cancer at the 15th Biennial Ovarian Cancer Research Symposium, co-presented by American Association of Cancer Research (AACR) and the Rivkin Center for Ovarian Cancer Research on Saturday, September 21, 2024 in Seattle Washington.

Kazia Therapeutics Announces Presentation of EVT801 Clinical Data at 15th Biennial Ovarian Cancer Research Symposium

SYDNEY , Sept. 12, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to announce that an agreement has been executed with QIMR Berghofer Medical Research Institute, one of Australia's foremost cancer research centres, to obtain an exclusive license to certain intellectual property rights in relation to combination therapies consisting of PI3K inhibitor drugs, and one or more immunotherapy or PARP inhibitor drugs (PI3K combination).

KAZIA EXECUTES LICENSING AGREEMENT WITH QIMR BERGHOFER

Australian biotech company Kazia Therapeutics (NASDAQ: KZIA ) stock rocked the market after reporting encouraging results from a Phase II/III trial for its glioblastoma brain cancer therapy Paxalisib.  The positive results extended the life of patients by over three months compared to the current standard of care.

Kazia Therapeutics Stock: Is KZIA a Buyout Candidate in the Making?

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Kazia (KZIA) surges after positive data from a phase II/III study on its lead pipeline drug in patients with glioblastoma. Based on this data, it plans to seek an accelerated nod from the FDA.

Kazia Therapeutics (KZIA) Soars 490% in a Week: Here's Why

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Kazia Therapeutics (NASDAQ: KZIA ) stock is continuing to rally on Thursday after the company reported positive alongside clinical trial data yesterday. The Kazia Therapeutics clinical trial covered the company's paxalisib as a treatment of glioblastoma.

KZIA Stock Alert: Kazia Continues Its Surge on Thursday With 51% Gains

Kazia Therapeutics Limited  KZIA released results on Wednesday from the GBM-AGILE Phase 2/3 study that included an evaluation of paxalisib versus standard of care (SOC) for patients with glioblastoma, a type of brain cancer.

Kazia Therapeutics Shares Are Jumping Today: Successful Study For Brain Cancer Treatment

Kazia Therapeutics (NASDAQ: KZIA ) stock is soaring higher on Wednesday after the oncology-focused biotechnology company provided results from a Phase II/III clinical trial. These results concern the effectiveness of paxalisib as a treatment of glioblastoma versus the standard of care (SOC).

Why Is Kazia Therapeutics (KZIA) Stock Up 300% Today?

GBM AGILE trial data shows clinically meaningful improvement in a prespecified secondary analysis for overall survival in paxalisib-treated, newly diagnosed unmethylated patients with glioblastoma SYDNEY , July 10, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to announce results from GBM-AGILE, a phase II/III study that included an evaluation of paxalisib versus standard of care (SOC) for patients with glioblastoma (NCT03522298), a life-threatening brain cancer, where there is an urgent unmet need for new therapeutics.  GBM AGILE STUDY GBM AGILE is an adaptive phase II/III global trial sponsored by the Global Coalition for Adaptive Research (GCAR), a nonprofit organization comprised of some of the world's foremost clinical, translational, and basic science researchers, from institutions such as Memorial Sloan Kettering Cancer Center and Dana-Farber Cancer Institute.

Kazia Therapeutics Announces Phase II/III Clinical Trial Results for Paxalisib in Glioblastoma

SYDNEY , June 27, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specialising in oncology, is pleased to announce the presentation of new data from its lead program, paxalisib, at the upcoming 21st International Symposium on Pediatric Neuro-Oncology (ISPNO 2024) June 29 – July 2, 2024, in Philadelphia, PA. Kazia concurrently announces  publication of an article in European Journal of Cancer highlighting the need for evaluating mutation-specific, CNS penetrant, inhibitors to treat pediatric patients with Diffuse Midline Glioma (DMG).

KAZIA ANNOUNCES UPCOMING DIPG DATA PRESENTATIONS AT ISPNO AND PUBLICATION IN EUROPEAN JOURNAL OF CANCER

SYDNEY , May 23, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) (Kazia or the company) received a letter on May 22, 2024 from Nasdaq notifying the Company that, while the Company has not regained compliance with the Minimum Bid Price Requirement, Nasdaq has determined that the Company is eligible for an additional 180 calendar day period, or until November 18, 2024 (the "Second Compliance Period"), to regain compliance with the Minimum Bid Price Requirement. As previously disclosed, on November 20, 2023, Kazia Therapeutics Limited (the "Company") received a deficiency notification from the Listing Qualifications Staff of the Nasdaq Stock Market LLC ("Nasdaq"), notifying the Company that it was not in compliance with the minimum bid price requirement as set forth in Nasdaq Listing Rule 5550(a)(2) (the "Minimum Bid Price Requirement").

Kazia Granted 180-Day Extension by Nasdaq to Meet the Minimum Bid Price Requirement

SYDNEY , May 1, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specialising in oncology, is pleased to announce that the Safety Review Team (SRT) of the EVT801 Phase 1 clinical trial has concluded that the primary and secondary objectives of stage 1 of the trial have successfully been met. Consisting of the trial's lead investigators, independent medical monitor, and key members from Kazia Therapeutics, the SRT has reviewed all preliminary (non-final) safety and pharmacokinetic (PK) data, and unanimously agreed that the maximal tolerated dose (MTD) has been reached at 500mg twice a day (BID).

KAZIA REPORTS SUCCESSFUL STAGE 1 COMPLETION OF THE EVT801 PHASE 1 CLINICAL TRIAL IN ADVANCED CANCER PATIENTS

SYDNEY , March 21, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specialising in oncology, is pleased to announce that it has entered into an exclusive licensing agreement with Sovargen Co., Ltd, a biotechnology company specializing in central nervous system (CNS) diseases, to develop, manufacture and commercialise paxalisib as a potential treatment of intractable epilepsy in focal cortical dysplasia type 2 (FCD T2) and tuberous sclerosis complex (TSC) disease. The underlying cause of FCD T2 and TSC can be traced back to somatic mutations in the PI3K/Akt/mTOR pathway or mutations in the TSC1 or TSC2 genes, which lead to the overactivation of the mTOR pathway.

Kazia Therapeutics licenses paxalisib to Sovargen for intractable seizures in rare central nervous system diseases

SYDNEY, March 13, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specialising in oncology, is pleased to announce the presentation of new data for both its pipeline molecules, paxalisib and EVT801, at the upcoming Annual Meeting of the American Association of Cancer Research (AACR) in San Diego, California, from 5-10 April 2024. There will be three presentations in total at AACR, including data from the phase 1 study of EVT801 in advanced solid cancers.

Kazia announces presentation of new data at AACR Annual Meeting

Paxalisib plus Radiotherapy Data Shows Promise for Treating Patients with PI3K Pathway Mutation Brain Metastases SYDNEY , Feb. 21, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specializing in oncology, today announced the early conclusion based on positive safety and promising clinical response findings observed to date of an important two-part Phase I trial. This investigator-initiated trial evaluated the use of paxalisib (an oral PI3K/mTOR dual inhibitor) with radiation therapy for the treatment of patients with PI3K pathway mutation brain metastases from solid tumors.

Kazia Therapeutics Reports Early Conclusion of Clinical Trial After Reaching Primary Endpoint

SYDNEY , Jan. 18, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to announce the appointment of pharma industry executive, Mr. Robert Apple to Kazia's Board of the Directors (the "Board") as a Non-Executive Director.

KAZIA CONTINUES BOARD RENEWAL WITH TWO NEW APPOINTMENTS

SYDNEY , Dec. 5, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused drug development company, today announced the closing of its previously announced purchase and sale of up to an aggregate of 4,444,445 of the Company's American Depositary Shares ("ADSs") (or ADS equivalents in lieu thereof), each ADS representing ten (10) ordinary shares of the Company, at a purchase price of $0.45 per ADS (or ADS equivalent in lieu thereof), in a registered direct offering. The Company also issued in a concurrent private placement unregistered warrants to purchase up to an aggregate of 4,444,445 ADSs.

Kazia Therapeutics Announces Closing of $2 Million Registered Direct Offering

SYDNEY , Dec. 1, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused drug development company, today announced that it has entered into a definitive agreement for the purchase and sale of up to an aggregate of 4,444,445 of the Company's American Depositary Shares ("ADSs") (or ADS equivalents in lieu thereof), each ADS representing ten (10) ordinary shares of the Company, at a purchase price of $0.45 per ADS (or ADS equivalent in lieu thereof), in a registered direct offering. The Company has also agreed to issue in a concurrent private placement unregistered warrants to purchase up to an aggregate of 4,444,445 ADSs.

Kazia Therapeutics Announces $2 Million Registered Direct Offering

SYDNEY , Nov. 29, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to announce that it has signed a non-binding Letter of Intent (LOI) with an undisclosed biotechnology company for the license of worldwide rights, other than mainland China, Hong Kong, Macao and Taiwan, to develop and commercialize pharmaceutical product containing paxalisib in an indication outside of cancer. Mutual due diligence has been completed and each company has agreed to move forward to negotiate and use their best efforts to agree to the terms of a definitive agreement.

KAZIA ANNOUNCES NON-BINDING LETTER OF INTENT FOR THE PROPOSED GRANTING OF RIGHTS TO DEVELOP AND COMMERCIALIZE PAXALISIB OUTSIDE OF ONCOLOGY

SYDNEY , Nov. 21, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to provide key highlights of the clinical and preclinical paxalisib related presentations given by key thought leaders at the Society of Neuro-Oncology 2023 Annual Meeting. "The 2023 SNO Annual Meeting was another successful event with the latest advances in clinical trials, diagnosis and treatment of pediatric and adult patients with CNS malignancies," stated Dr. John Friend, CEO Kazia.

KAZIA PROVIDES OVERVIEW OF PAXALISIB RELATED PRESENTATIONS FROM THE SOCIETY OF NEURO-ONCOLOGY 2023 ANNUAL MEETING

SYDNEY , Nov. 20, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA) (Kazia or the company) received a deficiency notification from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (Nasdaq), dated November 20, 2023, notifying the company that it is not in compliance with the minimum bid price requirement set forth in the Nasdaq Capital Market's rules for continued listing (the Notice). The deficiency notification has no immediate impact on the company's operations or listing.

KAZIA ANNOUNCES RECEIPT OF NASDAQ MINIMUM BID NOTIFICATION

SYDNEY , Nov. 15, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, is pleased to announce that the Society of Neuro-Oncology 2023 Annual Meeting late breaking abstract entitled "PNOC022: a combination therapy trial using an adaptive platform design for patients with diffuse midline gliomas (DMGs) at initial diagnosis, post-radiation therapy and at time of therapy" was released by the conference organizers on 10 November 2023. The preliminary results from a single cohort in this Pacific Pediatric Neuro-Oncology Consortium (PNOC) sponsored cooperative group clinical study will be presented on Sunday, 19 November 2023 in Vancouver, Canada.

KAZIA ANNOUNCES THE RELEASE OF PNOC022 CLINICAL STUDY ABSTRACT HIGHLIGHTING PAXALISIB IN DIFFUSE MIDLINE GLIOMA PATIENTS AHEAD OF THE SOCIETY OF NEURO-ONCOLOGY 2023 ANNUAL MEETING

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